Teleflex Medical
ATHLONE Westmeath, IE
TELEFLEX MEDICAL appears in FDA device records in ATHLONE Westmeath, IE. FDA records list 80 510(k) clearances between and , 15 PMA records and 4 registered establishments. As of , FDA records show 511 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
9 namesFDA records resolved to Teleflex Medical carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Rusch Increcall
- Telefelx Medicalrecall
- Teleflex Creek Drrecall
- Teleflex LLCregistration, 510(k), enforcement report, recall
- Teleflex Medical Europe Ltdenforcement report, recall
- TELEFLEX-MORRISVILLEenforcement report, recall
- Vasonova, Inc.510(k), enforcement report, recall
- Vidacare, LLC510(k), enforcement report, recall
- Weckrecall
510(k) clearance history
Showing 50 of 80FDA records hold 80 510(k) clearances for Teleflex Medical between 1986 and 2026. The busiest year on record is 2006, with 9. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1986 | 2 |
| 2003 | 1 |
| 2004 | 5 |
| 2005 | 5 |
| 2006 | 9 |
| 2007 | 6 |
| 2008 | 5 |
| 2009 | 3 |
| 2010 | 2 |
| 2011 | 2 |
| 2012 | 5 |
| 2013 | 5 |
| 2014 | 6 |
| 2015 | 1 |
| 2016 | 3 |
| 2018 | 4 |
| 2019 | 1 |
| 2020 | 2 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 3 |
| 2024 | 3 |
| 2025 | 3 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261988 | Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture | NEW | Substantially Equivalent | |
| K260775 | Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™ | GAT | Substantially Equivalent | |
| K251054 | Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips | FZP | Substantially Equivalent | |
| K242495 | LMA Fastrach ETT SU | BTR | Substantially Equivalent | |
| K243553 | QuikClot Control+ Hemostatic Device | POD | Substantially Equivalent | |
| K241784 | Arrow® Nitinol Wire | DQX | Substantially Equivalent | |
| K233713 | Pilling Tracheostomy Tubes | BTO | Substantially Equivalent | |
| K232970 | Hem-o-lok® Ligating Clips | FZP | Substantially Equivalent | |
| K230603 | Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnapLock Adapter (Luer Connection) (CA-000010-19); Arrow Non-Stimulating Next Gen SnapLock Adapter (Neuraxial Connection) (CA-000014-19); Arrow Stimulating SnapLock Adapter (with cable) (TZ-02060-001); Arrow Stimulating SnapLock Adapter (with tab) (TZ-05000-002) | BSO | Substantially Equivalent | |
| K231924 | EZ-IO Intraosseous Vascular Access System | FMI | Substantially Equivalent | |
| K230480 | Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML) | FZP | Substantially Equivalent | |
| K222279 | Rusch Intermittent Urethral Catheters | EZC | Substantially Equivalent | |
| K202492 | EZ-IO Intraosseous Vascular Access System | FMI | Substantially Equivalent | |
| K192490 | Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch | GAT | Substantially Equivalent | |
| K193530 | Deklene MAXX | GAW | Substantially Equivalent | |
| K190026 | Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit) | BSP | Substantially Equivalent | |
| K180253 | Sheridan Endobronchial Tubes | CBI | Substantially Equivalent | |
| K173321 | StimuQuik 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik 21G x 2.5cm (1”) Peripheral Nerve Block Needle | BSP | Substantially Equivalent | |
| K180588 | FAST1™ Intraosseous Infusion System; FASTResponder™ Sternal Intraosseous Device | FMI | Substantially Equivalent | |
| K173596 | Rusch Intermittent Urethral Catheters | EZC | Substantially Equivalent | |
| K161758 | Weck Auto Endo10 Automatic Endoscopic Clip Applier | FZP | Substantially Equivalent | |
| K153470 | MADgic Laryngo-Tracheal Mucosal Atomization Device | CCT | Substantially Equivalent | |
| K153652 | ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set | CAZ | Substantially Equivalent | |
| K140110 | FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET | BSO | Substantially Equivalent | |
| K142377 | The OnControl Bone Marrow Biopsy System by Vidacare | KNW | Substantially Equivalent | |
| K141940 | CONCHASMART COLUMN | BTT | Substantially Equivalent | |
| K140556 | CONCHASMART BREATHING CIRCUIT | BTT | Substantially Equivalent | |
| K141117 | EZ-IO INTRAOSSEOUS INFUSION SYSTEM | FMI | Substantially Equivalent | |
| K131912 | CONCHATHERM NEPTUNE HEATED HUMIDIFIER, COMFORT FLO HUMIDIFICATION SYSTEM, CONCHASMART COLUMN | BTT | Substantially Equivalent | |
| K132583 | EZ-IO INTRAOSSEOUS INFUSION SYSTEM | FMI | Substantially Equivalent | |
| K133202 | HEM-O-LOK LIGATING CLIP | FZP | Substantially Equivalent | |
| K132658 | HEMOCLIP TRADITIONAL LIGATING CLIPS, HEMOCLIP PLUS LIGATING CLIPS, HORIZON LIGTING CLIPS | FZP | Substantially Equivalent | |
| K130405 | RUSCH EASYCRIC EMERGENCY CRICOTHYROTOMY SET | BWC | Substantially Equivalent | |
| K123974 | PERCUTANEOUS INTRODUCER KIT | DYB | Substantially Equivalent | |
| K123813 | VASCULAR POSITIONING SYSTEM (VPS) G4 CONSOLE | OBJ | Substantially Equivalent | |
| K112958 | HUMID-VENT HEPA | CAH | Substantially Equivalent | |
| K121403 | CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET | CAZ | Substantially Equivalent | |
| K120661 | THE T.A.L.O.N. INTRAOSSOUS INFUSION SYSTEM BY VIDACRE | FMI | Substantially Equivalent | |
| K103658 | FLEXTIP PLUS CLOSED TIP EPIDURAL CATHERTER | CAZ | Substantially Equivalent | |
| K113872 | THE ONCONTROL BONE ACCESS AND BONE BIOPSY SYSTEM BY VIDACARE | KNW | Substantially Equivalent | |
| K103260 | VASCULAR POSITIONING SYSTEM (VPS SYSTEM) CONSOLE | OBJ | Substantially Equivalent | |
| K103255 | VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLET | OBJ | Substantially Equivalent | |
| K101026 | POWERED PD-IO INFUSION SYSTEM, EZ-IO HUMERAL HEAD, POWERED PH-IO | FMI | Substantially Equivalent | |
| K100506 | FORCE FIBER GREEN ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES MODEL:X-5000FFK, X-5001FFK, X-5002FFK | GAT | Substantially Equivalent | |
| K091924 | VPS CATHETER | LJS | Substantially Equivalent | |
| K091140 | EZ-MIO DISTAL TIBIA, EZ-IO DISTAL TIBIA, VIDAPORT INTRAOSSEOUS INFUSION SYSTEM, EZ-IO | FMI | Substantially Equivalent | |
| K083920 | FLOWPICC CATHETER | LJS | Substantially Equivalent | |
| K082481 | FLOWPICC CATHETER | LJS | Substantially Equivalent | |
| K081713 | VERTEBRAL ACCESS SYSTEM BY VIDACARE | MOQ | Substantially Equivalent | |
| K081626 | FLOWPICC CONSOLE | OBJ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007134520 | 3007134520 | TELEFLEX MEDICAL | IDA BUSINESS AND TECHNOLOGY PARK, ATHLONE Westmeath -- IE | 2026 | |
| 3030236028 | 3030236028 | Teleflex LLC | 9491 Winnetka Avenue, Brooklyn Park, MN 55445 US | 2026 | |
| 3012481535 | 3012481535 | Teleflex Medical Inc. | 4300 Glendale Milford Road, Cincinnati, OH 45242 US | 2026 | |
| 3011137372 | 3005747797 | Teleflex Medical LLC | 3015 Carrington Mill Blvd, Morrisville, NC 27560 US | 2026 | and 537 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- BTQAirway, Nasopharyngeal
- CAEAirway, Oropharyngeal, Anesthesiology
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- CCLAnalyzer, Gas, Oxygen, Gaseous-Phase
- CAZAnesthesia Conduction Kit
- CACApparatus, Autotransfusion
- CBNApparatus, Gas-Scavenging
- CCTApplicator (Laryngo-Tracheal), Topical Anesthesia
- BYEAttachment, Breathing, Positive End Expiratory Pressure
- CBOAttachment, Intermittent Mandatory Ventilation (Imv)
- BTCBag, Reservoir
- CATCannula, Nasal, Oxygen
- BSOCatheter, Conduction, Anesthetic
- DQOCatheter, Intravascular, Diagnostic
- DQYCatheter, Percutaneous
- CAICircuit, Breathing (W Connector, Adaptor, Y Piece)
- DSSClip, Vascular
- BYDCondenser, Heat And Moisture (Artificial Nose)
- BZAConnector, Airway (Extension)
- BSKCuff, Tracheal Tube, Inflatable
- CBHDevice, Fixation, Tracheal Tube
- BYWDevice, Rebreathing
- DWPDilator, Vessel, Surgical
- CAHFilter, Bacterial, Breathing-Circuit
- BWBForceps, Tube Introduction
- BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
- BTTHumidifier, Respiratory Gas, (Direct Patient Interface)
- CALLaryngoscope, Non-Rigid
- CCWLaryngoscope, Rigid
- BSJMask, Gas, Anesthetic
- CAPMonitor, Airway Pressure (Includes Gauge And/Or Alarm)
- BYPMouthpiece, Breathing
- CCQNebulizer, Medicinal, Non-Ventilatory (Atomizer)
- DWONeedle, Biopsy, Cardiovascular
- BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)
- BWCNeedle, Emergency Airway
- DQTOccluder, Catheter Tip
- BRWProtector, Dental
- BZOSet, Tubing And Support, Ventilator (W Harness)
- DTISizer, Heart-Valve, Prosthesis
- BWFSpirometer, Therapeutic (Incentive)
- CBGSpreader, Cuff
- BZWStethoscope, Esophageal
- BTKStrap, Head, Gas Mask
- DWQStripper, Vein, External
- DRBStylet, Catheter
- BSRStylet, Tracheal Tube
- CCXSupport, Patient Position
- BYLTent, Oxygen
- DRCTrocar
- BYYTube, Aspirating, Flexible, Connecting
- BTSTube, Bronchial (W/Wo Connector)
- BTRTube, Tracheal (W/Wo Connector)
- CBITube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
- BTOTube, Tracheostomy (W/Wo Connector)
- BYXTubing, Pressure And Accessories
- CBPValve, Non-Rebreathing
- BTMVentilator, Emergency, Manual (Resuscitator)
- DQXWire, Guide, Catheter
Recall records
Showing 25 of 511| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2639-2026 | Brand Name: Pilling Wecksorb Product Name: Pilling Wecksorb Neurosponges (Cotton) Pilling Wecksorb Neurosponge Strips (Cotton) Model/Catalog Number: 200100 200101 200102 200103 200104 200105 200106 200108 200110 200112 200120 200121 200123 200131 Software Version: N/A Product Description: Wecksorb Neurosponges are made of an absorbent cotton material. Certain Neurosponge varieties are available with an x-ray detectable thread to assist with location within the surgical site. Some Neurosponges (patties) have a string for accountability during the post-surgical verification process. Wecksorb Neurosponges are for use in the protection of tissue during surgical procedures; tissues include the brain and other central nervous system tissues. Neuro sponges are used during cranial and spine surgery to moisten the dura or to cushion against bone edges. They are also used to protect brain tissue under the dura or elsewhere during incision. Component: N/A | Due to out-of-specification, or potential out-of-specification, levels of endotoxins | Class II | Open, Classified | |
| Z-2097-2023 | Pilling LOWSLEY PROSTATIC TRACTOR STR, REF 243201; retractor | There are incomplete pre-cleaning instructions within the Instructions for Use (IFU). | Class II | Open, Classified | |
| Z-2096-2023 | Pilling LOWSLEY PROSTATIC TRACTOR CVD, REF 243200; retractor | There are incomplete pre-cleaning instructions within the Instructions for Use (IFU). | Class II | Open, Classified | |
| Z-2095-2023 | Pilling O'REILLY ESOPHAGEAL RETRACTOR, REF 381801A; ENT retractor | There are incomplete pre-cleaning instructions within the Instructions for Use (IFU). | Class II | Open, Classified | |
| Z-1905-2023 | Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150055 | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | Class I | Open, Classified | |
| Z-1904-2023 | Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150040 | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | Class I | Open, Classified | |
| Z-1903-2023 | Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150035 | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | Class I | Open, Classified | |
| Z-1902-2023 | Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150030 | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | Class I | Open, Classified | |
| Z-1901-2023 | Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150025 | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | Class I | Open, Classified | |
| Z-1900-2023 | Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150020 | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | Class I | Open, Classified | |
| Z-1899-2023 | RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480045 | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | Class I | Open, Classified | |
| Z-1898-2023 | RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480040 | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | Class I | Open, Classified | |
| Z-1897-2023 | RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480035 | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | Class I | Open, Classified | |
| Z-1896-2023 | RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480030 | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | Class I | Open, Classified | |
| Z-1895-2023 | RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480025 | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | Class I | Open, Classified | |
| Z-1894-2023 | Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082100 | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | Class I | Open, Classified | |
| Z-1893-2023 | Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082095 | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | Class I | Open, Classified | |
| Z-1892-2023 | Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082090 | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | Class I | Open, Classified | |
| Z-1891-2023 | Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082085 | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | Class I | Open, Classified | |
| Z-1890-2023 | Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082080 | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | Class I | Open, Classified | |
| Z-1889-2023 | Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082075 | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | Class I | Open, Classified | |
| Z-1888-2023 | Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082070 | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | Class I | Open, Classified | |
| Z-1887-2023 | Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082065 | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | Class I | Open, Classified | |
| Z-1886-2023 | Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082060 | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | Class I | Open, Classified | |
| Z-1885-2023 | Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082055 | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. | Class I | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain